Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79705–79728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2001
CLARREN HELMET
K003035 · MVA
Children'S Hospital & Medical Center
Neurology · 251d
Cleared Jun 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · MJA
Bd Becton Dickinson Vacutainer...
Microbiology · 247d
Cleared Jun 06, 2001
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
K003517 · MCF
Otres, LLC
Dental · 204d
Cleared Jun 06, 2001
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 198d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596 · IPF
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared Jun 06, 2001
CPR EZY MASK AND PAD
K003937 · LIX
Medteq Innovations Pty, Ltd.
Cardiovascular · 168d
Cleared Jun 06, 2001
STIMUPLEX HNS-11
K003983 · BXN
Stockert GmbH
Anesthesiology · 162d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · DTK
Cordis Corp.
Cardiovascular · 146d
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · MNI
Synthes
Orthopedic · 145d
Cleared Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · KFF
International Technidyne Corp.
Hematology · 135d
Cleared Jun 06, 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
SPARROWHAWK DISPOSABLE
K010473 · DWZ
Atc Technologies, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
TBW
K010545 · NDL
Tri-Med, Inc.
Orthopedic · 103d
Cleared Jun 06, 2001
UNIQUE AMBULATORY EEG
K010697 · GWQ
Axon Systems, Inc.
Neurology · 90d
Cleared Jun 06, 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN...
K010856 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 76d
Cleared Jun 06, 2001
TEMP-A-SURE
K010866 · FLL
Homecare Technologies , Ltd.
General Hospital · 76d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · MNI
Endius, Inc.
Orthopedic · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · MNI
Endius, Inc.
Orthopedic · 71d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
K010963 · GGP
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Jun 06, 2001
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
K011055 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 61d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · PJD
OraSure Technologies, Inc.
Toxicology · 61d
Cleared Jun 06, 2001
TPO IGG ANTIBODY EIA TEST
K011082 · JZO
Scimedx Corp.
Immunology · 57d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d